Revision Year: 2007
Patients with congenital deficiency.
a) Prophylaxis of deep vein thrombosis and thromboembolism in clinical risk situations
(especially during surgery or during peri-partum period), in association with heparin if indicated.
b) Prevention of progression of deep vein thrombosis and thromboembolism in association with heparin as indicated.
Acquired antithrombin deficiency as in connection with heparin resistance associated with low antithrombin values, e.g. in surgery with the support of heart-lung machine (also see section 4.4 and 5.1)
Treatment should be initiated under the supervision of a physician experienced in the treatment of patients with deficiency of antithrombin.
Physiology
Dosage should be individualised for each patient taking into account the family history with regard to thromboembolic events, the actual clinical risk factors, and the laboratory assessment.
Dosage and duration of the substitution treatment depends on the severity of the disease and the clinical condition. The dosage is individually dependent on the patient’s needs based on the doctor’s medical assessment and laboratory values.
One antithrombin III unit corresponds to the quantity of antithrombin III present in 1 mL pooled normal human plasma. This concentration is established at 100 %. Administration of 1 IU antithrombin III per kg body weight increases the antithrombin III concentration (activity) by approximately 1 %.
The dose requirement is calculated according to the following formula: Number of units (dose) = body weight (kg) x (100 – current antithrombin III activity (in %)).
Initially, an antithrombin III level of at least 100% should be achieved, and this should be kept beyond 80 % during the treatment.
The dose should be defined after determination of the patient’s antithrombin III activity.
This should be determined at least twice a day until the patient is stabilised, then daily and always immediately before the next infusion. It should be remembered that the plasma half life of antithrombin III can be reduced considerably in certain clinical situations, such as disseminated intravascular coagulation.
Dissolve the preparation as described in section 6.6 and slowly inject or infuse the solution intravenously.
The infusion rate for adults should not exceed 300 IU/min.
The preparation should be administered within 12 hours.
No symptoms of overdose with antithrombin have been reported.
Shelf life: 36 months (infusion vial).
The reconstituted solution should be used within 12 hours.
To be stored at 2°C to 8°C.
Within its shelf-life the product may be stored at 25°C for up to one month, without being refrigerated again during this period, and must be withdrawn if not used after this.
Injection vial of type II glass (Ph.Eur.), 50 or 100 mL with a bromobutyl rubber stopper sealed with an aluminium pull-off cap.
The freeze-dried powder is reconstituted in sterile water for injection.
After reconstitution Atenativ may be mixed with isotonic sodium chloride solution (9 mg/mL) and/or isotonic glucose solution (55 mg/mL) in glass infusion vials as well as plastic containers.
Atenativ should not be used after the expiry date, as indicated on the packaging.
Normally, the solution is clear or slightly opalescent. Do not use solutions that are cloudy or contain sediment.
The reconstitution time is 5 minutes at the most. After reconstitution, the product should be used as soon as possible and within 12 hours.
Discard any unused solution.
Any unused product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
